MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth: unk.Patient's weight: unk.Patient's ethnicity/race: unk.Relevant tests/laboratory data: unk.Device lot, expiration date: unk.A portion of the device remained in the patient and the other portion discarded, thus no investigation could be performed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) icd lead due to suspected lead fracture.A rv pacing lead and a left ventricular (lv) were present in the patient as well, but were not targeted for extraction.The patient had a history of prior extraction and multiple generator changes.A spectranetics lead locking device (lld) was placed into the rv lead to provide traction.The physician used a spectranetics 16f glidelight laser sheath to extract the lead.Heavy binding was present from vessel entry down the subclavian and innominate veins.As the physician was lasing down the rv lead low in the right atrium, he experienced stalled progression.Lasing and traction was being performed, and the patient''s blood pressure dropped.The physician released traction, but the blood pressure did not rebound.Medications and volume were given.The physician made a sub xiphoid incision and got access to the pericardium to perform a pericardiocentesis.He performed other interventions that gave him visibility.Another ct surgeon came to assist.With the medications and volume given, the patient''s blood pressure stabilized.The physicians agreed that the bleeding stopped and it was safe to proceed with the extraction.The physician used the 16f glidelight device and a spectranetics visisheath dilator sheath and was able to advance down to where progress initially stalled.He alternated between lasing and using the visisheath over the ingrowth.Unable to get through the binding, the physician asked for another spectranetics device to attempt progression.A minute later, after removing the glidelight device and visisheath from the patient, the patient''s blood pressure dropped again.The physician went back to the sub xiphoid incision and sucked out more blood from the pericardial space.The physicians then performed a sternotomy, and a right atrial perforation was discovered, which the physician occluded with his finger.Patient was placed on bypass.Upon closer inspection, there was a small superior vena cava (svc) perforation discovered at the svc/ra junction as well (mdr #1721279-2021-00238).Rescue efforts continued, repairs to the perforations were successful, and the patient survived the procedure.The rv lead was not removed; the physician did not attempt to unlock the lld from the rv lead, and the lld within the rv lead were both cut and capped and remained in the patient.This report captures the lld present within the rv lead which was cut and capped and remained in the patient.Although there was no alleged malfunction of the lld during the procedure, this is also being reported for product problem since a portion of the lld remained in the patient.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13011791
• MDR Text Key: 285357207
• Report Number: 1721279-2021-00240
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 5076 RV PACING LEAD; MEDTRONIC 6935M RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1458Q LV LEAD
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female